Use of Carboxymethylcellulose/Polyethylene Oxide Gel in Microdiscectomy With Interlaminectomy

Abstract

CMC/PEO gel after microdiscectomy with interlaminectomy appears safe to use and in a 3-year follow-up significantly reduces disability and leg pain scores compared with our conventional treatment.

Reduction of Leg Pain by Oxiplex Gel After Lumbar Discectomy in Patients With Predominant Leg Pain and Elevated Levels of Lower Back Pain

“…The difference in favor of Oxiplex ranged from 15% to 26% and duration of this benefit persisted for at least 6 months. 12,13 The results of this investigation demonstrated that Oxiplex had a statistically significant and clinically meaningful effect on the degree of reduction in leg pain from baseline, which confirms the findings from the studies performed in the United States 13 and Italy. 12 These observations support the role of Oxiplex in reducing leg pain among challenging patients with concomitant severe baseline back pain.…”

“…This significant reduction in leg pain (P = 0.0240) confirmed previous reports of significant reduction in leg pain from similar surgical procedures performed in Italy (26%, P = 0.0008, Assietti et al12 ) and the United States (P = 0.0123, Rhyne et al13 ).…”

“…These results are compared with 2 similar studies that were independently performed in the United States 13 and Italy. 12 In all 3 studies, the use of Oxiplex resulted in a statistically significantly greater reduction in leg pain in patients who had severe preoperative back pain compared with surgery-only controls. This is a randomized, controlled study in which preoperative (baseline) and postoperative leg and back pain were measured to evaluate the efficacy of Oxiplex gel in reducing postoperative pain and symptoms beyond that achieved by surgery alone.…”

“…In clinical studies in the United States and Italy, the gel was found to reduce postoperative leg pain and associated symptoms after decompression surgery. [10][11][12][13] Interestingly, the reduction of leg pain in patients with both leg pain and severe LBP was significantly greater than in the overall study cohort in a US study of 352 subjects when Oxiplex was used. 13 To further evaluate the potential utility of Oxiplex, a follow-up clinical study was performed in subjects with LDH undergoing decompression surgery.…”

“…The study was powered at 80% to show a difference in leg pain at P < 0.05 level based on results from a previous feasibility study. 11,12 For safety analyses, the Fisher exact test was used except where otherwise specified to assess statistical significance, and a 2-sided P < 0.05 was considered to be significant.…”